FDA-Device2021-10-13Class II
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Philips Ultrasound Inc
Hazard
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany.
Affected count
34 units
Manufactured in
22100 Bothell Everett Hwy, Bothell, WA, United States
Products
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2022Don't want to check this manually?
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